MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-06-14 for TENSION FREE VAGINAL TAPE 810081 manufactured by Ethicon, Inc..
[417803]
It was reported that the pt underwent a sling procedure in 2005. Post operatively the patient began experiencing leg pain in the adductor area. The pt was prescribed pain medication. Pt also used packs and ben gay to control the pain. The following month, the pt was referred to a physical therapist and continues on pain medication.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2005-00352 |
| MDR Report Key | 613243 |
| Report Source | 05,06 |
| Date Received | 2005-06-14 |
| Date of Report | 2005-05-19 |
| Date of Event | 2005-05-17 |
| Date Facility Aware | 2005-05-17 |
| Report Date | 2005-05-19 |
| Date Mfgr Received | 2005-05-19 |
| Date Added to Maude | 2005-06-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MARK YALE |
| Manufacturer Street | ROUTE 22 WEST P.O. BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 0082182326 |
| Manufacturer G1 | ETHICON SARL A JOHNSON & JOHNSON CO |
| Manufacturer Street | RUE DE PUITS GODET 20 |
| Manufacturer City | NEUCHATEL 2000 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TENSION FREE VAGINAL TAPE |
| Generic Name | MESH, SURGICAL, POLYMERIC |
| Product Code | MCD |
| Date Received | 2005-06-14 |
| Model Number | NA |
| Catalog Number | 810081 |
| Lot Number | 1288947 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 603071 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US |
| Baseline Brand Name | TENSION FREE VAGINAL TAPE |
| Baseline Generic Name | MESH, SURGICAL, POLYMERIC |
| Baseline Model No | NA |
| Baseline Catalog No | 810081 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2005-06-14 |